OIG Workplan

OIG Work Plan: Agency to Focus on Vaccine Adverse Event Reporting

The five new items the OIG added to its Work Plan in December 2019 have no direct impact on labs or lab services, although three of them might have an indirect effect on some labs. Here’s the … [Read more...]

Labs In Court A roundup of recent cases and enforcement actions involving the diagnostics industry

Court Refuses to Let M.D./Executives Out of Their Non-Competes  Case: After leaving the national reference lab in which they owned equity and served as executives, a pair of Georgia pathologists … [Read more...]

EKRA

EKRA: More than a Year Out, Major Questions Remain Unresolved

One of the scariest new lab compliance laws in recent memory is the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). While laws banning remuneration in exchange for referrals is nothing new to … [Read more...]

COMPLIANCE

Sales & Marketing: The Perils of Restructuring Sales Commissions for EKRA

For many years, it was fairly common practice for labs to pay their sales representatives variable compensation based on the volume and value of the tests they generated. But those arrangements became … [Read more...]

Beyond the News: What Does Latest ACA Court Ruling Really Mean?

You’ve no doubt heard the news about the Dec. 18 federal appeals court ruling striking down part of the Affordable Care Act (ACA) as unconstitutional. But like most people, you’re probably wondering … [Read more...]

Compliance Perspectives: New Laws & the Top 5 Challenges Lab Compliance Officers Face in 2020

Labs remain at the forefront of the federal government’s suspicious persons list and health care fraud enforcement agenda. But in addition to the customary laws that labs are used to, the government … [Read more...]

Genetic Testing

Precision Medicine: Are Primary Care Providers Prepared to Interpret Genetic Testing Results?

Specialists might be the best choice to interpret genetic testing results, but primary care providers may be positioned to do so when specialists are not available, a new study has found. And that is … [Read more...]

Genetic Tests: NCCN Updates Genetic Breast, Ovarian & Pancreatic Testing Guidelines

On Dec. 4, the National Comprehensive Cancer Network (NCCN) issued updated guidelines for use of genetic testing to assess the risk of breast, ovarian and pancreatic cancer. The headliners of the new … [Read more...]

Genetic Testing: Proposed New Medicare Coverage Rules for NGS Germline Testing of Early-Stage Cancer Patients

Medicare coverage of germline next-generation sequencing (NGS) panels for early-stage cancer patient has been a topic of controversy of late. The problem began when the Centers for Medicare and … [Read more...]

Emerging Tests: New Study Supports Feasibility of At-Home Urine Prostate Cancer Testing

One of the most challenging aspects of prostate cancer diagnosis is collecting urine samples from patients. In addition to being highly uncomfortable, post-digital rectal examination collection yields … [Read more...]


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